MAUDE Adverse Event Report: JACKSON, INC. SUPRAFOIL; STENTE SUPRAFOIL SMOOTH NYLON FOIL SHEETS

Device Problems Fracture (1260); Expiration Date Error (2528)

Patient Problem Fall (1848)

Event Date 02/11/2019

Event Type  malfunction  

Event Description

On (b)(6) 2019, (b)(6) years old male admitted with orbital fracture sustained from fall at home.On (b)(6) 2019 surgical repair completed.On 02/12/2019 audit of suprafoil implant revealed there was no expiration date on the product.Further inquiry with the manufacturer revealed that the lot number is also the implant date.It was then discovered that the implant was expired.The following was received from the company as part of the investigation: our products have been marketed since the 1950's and packaging and labeling has evolved over the years.We originally marketed our products with a statement that ¿product is sterile unless the packaging is open or damaged.¿ the fda in the 1980's requested we use a lot number as an expiration date for stock rotation purposes only.Prior to august 19, 2016 the expiration date was the lot # in mm/dd/yy format.For example, lot # 021416 expired on february 15, 2016.The use of the lot number as an expiration date was stated on our package insert.The facility was told by the company that no recall of products with lot number as expiration dates was sent out and no notice/letter was sent out regarding the above described changes.No harm to patient.

• Brand Name: SUPRAFOIL
• Type of Device: STENTE SUPRAFOIL SMOOTH NYLON FOIL SHEETS
• Manufacturer (Section D): JACKSON, INC.
• MDR Report Key: 8371230
• MDR Text Key: 137538736
• Report Number: MW5084364
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR